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May 2013

FDA Delays Decision to Remove Powdered Gloves

Author Affiliations

Author Affiliations: Department of Plastic Surgery, Biomedical Engineering, and Emergency Medicine, University of Virginia School of Medicine, Charlottesville.

JAMA Surg. 2013;148(5):406-407. doi:10.1001/jamasurg.2013.30

The Food and Drug Administration (FDA) requires scientists to prepare a Citizen Petition to request changes in its mandatory regulations regarding the safety of drugs and devices.

In 2008, a comprehensive review article on the Citizen Petition to the FDA to ban cornstarch powder on medical gloves was published.1 The focus of this article was to discuss in detail the contents of the petition submitted to the FDA. Research has shown that areas in which powdered latex gloves were used were up to 300 times more aerosolized with latex proteins than when only powder-free low-allergen latex gloves were used.2 In addition to the potential for aerosolizing latex proteins, cornstarch powder can contaminate recovered transplant tissue and may lead to adverse reactions or rejections of the tissue by the recipient, among numerous other potential complications that are discussed within the petition.

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